Ampoules have been used to contain solutions, particularly, active agents such as drugs, for many years. Such ampoules have typically been designed to avoid contamination of or to maintain the sterility of solutions stored therein. For example, some ampoules have been made of glass that is sealed shut after a solution is placed therein. In order to access the solution inside, a top part of the ampoule is cut open, sometimes causing small bits of glass to fall into the interior of the ampoule.
Other ampoules are made of glass or plastic with an opening sealed by a stopper after a solution is placed in the ampoule. The stopper is designed to be punctured by a needle or other sharp object, so that the solution contained in the ampoule can be drawn therefrom. The force required to pierce the stopper often causes users to accidentally strike themselves with the sharp object used, causing abrasions or even deep puncture wounds.
U.S. Pat. No. 5,451,344 by Roger Molina discloses an ampoule stopper designed to avoid the dangers of puncturing, described briefly above. The '344 patent discloses a stopper designed to fit the opening in an ampoule or other vessel, with an opening in the stopper extending from the interior of the ampoule to the exterior, through a male luer connection, complimentary to a connection on a cap. This makes the contents of an ampoule fitted with the modified stopper easily removable. However, it also increases the risk of contamination of the contents of the ampoule.
Filtration systems have been designed to filter solutions from ampoules and other types of containers. For example, U.S. Pat. No. 4,076,027 by Elmer Koenig, discloses a device designed to receive a glass ampoule of the first type described above, after the top of the ampoule has been removed to create an opening through which solution contained therein can be accessed. The device includes a chamber of flexible plastic for receiving the ampoule in an upright position with the opening in the ampoule at the top. The device further includes a filter positioned above the opening in the ampoule, and a body with a cylindrical upper end surrounding the filter, configured to receive a female luer tapered connection. The filter is designed to remove particles of glass from the solution, as a solution is drawn out of the ampoule through the filter and luer connection. This device is clearly only designed to accommodate glass ampoules designed to be broken to access material contained therein, and to filter glass particles therefrom. It is not designed to sterilize solutions as they are removed from an ampoule, nor to prevent contamination of the contents of an ampoule, once it is opened.
Accordingly, what is needed is a container system for a solution that enables multiple doses of the solution to be administered in a sterile form, without contamination.